47 Randomized controlled trial comparing botulinum versus surgery for drooling in neurodisabilities 2 This study provides Class III evidence that for children and adolescents with neurodevelopmental disabilities and severe drooling, 2-DL compared to a onetime intraglandular submandibular BoNT-A injection is more effective at reducing drooling at 32 weeks. Secondary outcome measures 1. Changes in VAS following 2-DL and BoNT-A. 2. Changes in DQ following 2-DL and BoNT-A. 3. Response to treatment 8 weeks after treatment. 4. Changes in Drooling Severity (DS) and Drooling Frequency scale (DF) after 8 and 32 weeks. 5. Procedural time. 6. Complaints as reported by caregivers in a diary over the first two weeks postoperatively. 7. Adverse events. These were graded as related or unrelated to the intervention, and Adverse Events (AE) or Serious Adverse Events (SAE) when potentially life threatening, requiring prolonged hospitalization or causing permanent damage.20 Pain, dysfagia, xerostomia for less than 7 days were considered normal postoperative course. Statistical analysis. The sample size was estimated based on outcomes in previous studies. Forty percent response to BoNT-A and 80% response to 2-DL indicates that 26 patients per arm would provide 80% power to detect a difference with a type 1 error rate of 5% including a 10% dropout rate. Analyses were by intention to treat unless otherwise stated. Data analysis included descriptive statistics to summarize demographics; Pearson’s chi-squared statistics to treatment response; mixed model analyses with random intercepts was performed to test whether change in VAS and DQ differ between interventions; unpaired samples t-test to procedural time, total days of complaints, and number of adverse events and Wilcoxon rank test to change in DS/DF in subsequent visits. We report p-values, and differences (absolute risk reduction) and numbers needed to treat (NNT) bounded by confidence intervals (CIs) when applicable.
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